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Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone (ARTS-HF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01807221
First received: March 7, 2013
Last updated: September 26, 2014
Last verified: September 2014

March 7, 2013
September 26, 2014
June 2013
November 2014   (final data collection date for primary outcome measure)
Relative decrease in N-terminal prohormone B-type natriuretic peptide (NT-proBNP) [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01807221 on ClinicalTrials.gov Archive Site
  • Change in serum potassium [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
  • Change in blood pressure [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
  • Change in heart rate [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 120 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone Versus Eplerenone

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it is safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses will be compared to eplerenone, another marketed drug approved to treat heart failure.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Drug: Finerenone (BAY94-8862)
  • Drug: Placebo
  • Drug: Inspra (eplerenone)
  • Experimental: Finerenone(BAY94-8862)[2.5mg] + Placebo
    Oral - 2.5mg once daily (OD) for 30 days. Potential up-titration to 5mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
    Interventions:
    • Drug: Finerenone (BAY94-8862)
    • Drug: Placebo
  • Experimental: Finerenone (BAY94-8862)[5mg] + Placebo
    Oral - 5mg OD for 30 days. Potential up-titration to 10 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
    Interventions:
    • Drug: Finerenone (BAY94-8862)
    • Drug: Placebo
  • Experimental: Finerenone (BAY94-8862)[7.5mg] + Placebo
    Oral - 7.5mg OD for 30 days. Potential up-titration to 15 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
    Interventions:
    • Drug: Finerenone (BAY94-8862)
    • Drug: Placebo
  • Experimental: Finerenone (BAY94-8862)[10mg] + Placebo
    Oral - 10mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
    Interventions:
    • Drug: Finerenone (BAY94-8862)
    • Drug: Placebo
  • Experimental: Finerenone (BAY94-8862)[15mg] + Placebo
    Oral - 15mg OD for 30 days. Potential up-titration to 20 mg OD after 30 days or 60 days. Treatment duration 90 days. Placebo OD for 90 days.
    Interventions:
    • Drug: Finerenone (BAY94-8862)
    • Drug: Placebo
  • Active Comparator: Eplerenone [25 mg] + Placebo
    Oral - 25mg every other day (EOD). Potential up-titration to 25mg OD after 30 days and 50mg OD after 60 days.Placebo OD for 90 days.
    Interventions:
    • Drug: Placebo
    • Drug: Inspra (eplerenone)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1058
December 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
  • Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
  • Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
  • Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
  • Subjects with type 2 diabetes mellitus and / or
  • Subjects with 30 mL/min/1.73m2 </= eGFR </= 60 mL/min/1.73m2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
  • Left ventricular ejection fraction (LVEF) </= 40%
  • Blood potassium </= 5.0 mmol/L at screening
  • Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the screening visit

Exclusion Criteria:

  • Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
  • Acute coronary syndrome (ACS) in last 30 days prior to screening
  • Cardiogenic shock
  • Valvular heart disease requiring surgical intervention during the course of the study
  • Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
  • Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Bulgaria,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Lithuania,   Netherlands,   Norway,   Poland,   Portugal,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey
 
NCT01807221
14564, 2012-002627-15
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP